TITLE

Influence of trial design, heterogeneity and regulatory environment on the results of clinical trials: An appraisal in the context of recent trials on acute stroke intervention

AUTHOR(S)
Srijithesh, P. R.; Husain, Shakir
PUB. DATE
October 2014
SOURCE
Annals of Indian Academy of Neurology;Oct2014, Vol. 17 Issue 4, p365
SOURCE TYPE
Academic Journal
DOC. TYPE
Article
ABSTRACT
The outcome of randomized controlled trials can vary depending on the eligibility criteria of the patients entering into the trial, as well as the heterogeneity of the eligible population and/or the interventions. If the subject population and/or interventions are heterogeneous, the final outcome of the trial depends on the degree of concordance of effects of the subgroups of interventions on the subgroups of the subject population. The considerations that go into the calculation of sample size and determination of the study stopping rules also would affect the nature of the outcome of the study. In this paper we try to examine these phenomena with respect to the recent trials on endovascular therapy in acute ischemic stroke.
ACCESSION #
99563136

 

Related Articles

  • Innovative study design for paediatric clinical trials. Baiardi, Paola; Giaquinto, Carlo; Girotto, Silvia; Manfredi, Cristina; Ceci, Adriana // European Journal of Clinical Pharmacology;May2011 Supplement 1, Vol. 67, p109 

    Purpose: Despite representing a fundamental step towards the efficacious and safe utilisation of drugs in the paediatric population, the conduct of clinical trials in children poses several problems. Methodological issues and ethical concerns represent the major obstacles that have traditionally...

  • Design and analysis considerations in the Ebola_Tx trial evaluating convalescent plasma in the treatment of Ebola virus disease in Guinea during the 2014–2015 outbreak. Edwards, Tansy; Semple, Malcolm G.; De Weggheleire, Anja; Claeys, Yves; De Crop, Maaike; Menten, Joris; Ravinetto, Raffaella; Temmerman, Sarah; Lynen, Lutgarde; Bah, Elhadj Ibrahima; Smith, Peter G.; van Griensven, Johan // Clinical Trials;Feb2016, Vol. 13 Issue 1, p13 

    The Ebola virus disease outbreak in 2014–2015 led to a huge caseload with a high case fatality rate. No specific treatments were available beyond supportive care for conditions such as dehydration and shock. Evaluation of treatment with convalescent plasma from Ebola survivors was...

  • Alternatives to parallel group design suggested for trials.  // British Journal of Hospital Medicine (17508460);2015, Vol. 76 Issue 7, p383 

    The article reports on the research on alternatives to parallel group design suggested for trials to make it cheaper and easier to run, referencing a study by R. Hooper and L. Bourke published in a 2015 issue of "British Medical Journal."

  • Clinical and research databases in healthcare research. Firth, Jill; Reay, Naomi // Nurse Researcher;2008, Vol. 15 Issue 4, p27 

    The article explores the experiences of two nurse researchers on using clinical and research databases to find potential participants for research and discusses implications for conduct of research and its impact on response rates. It emphasizes the importance of sample size to clinical research...

  • Designing a research protocol in clinical dermatology: Common errors and how to avoid them. Panda, Saumya // Indian Journal of Dermatology, Venereology & Leprology;Mar/Apr2015, Vol. 81 Issue 2, p115 

    The author reflects on how to design a research protocol in clinical dermatology including common errors and ways to avoid them. Topics include the title of the research protocol, primary and secondary objectives, and methodology. Other topics include bias in clinical trials, research subjects,...

  • CONSORT 2010 statement: updated guidelines can improve wound care. Weller, C.; McNeil, J. // Journal of Wound Care;Aug2010, Vol. 19 Issue 8, p347 

    There is a growing need to add to the evidence base in wound care. Randomised controlled trials (RCTs) are one methodological approach for this. The CONSORT statement, which provides guidance on how to conduct a rigorous RCT, was updated earlier this year. Implementation of the Consort statement...

  • After Inclusion, Information and Inference: Reporting on Clinical Trials Results After 15 Years of Monitoring Inclusion of Women. Foulkes, Mary A. // Journal of Women's Health (15409996);Jun2011, Vol. 20 Issue 6, p829 

    Objective: The objectives of this report are to review the publications resulting from National Institutes of Health (NIH)-funded phase 3 trials monitored by NIH for inclusion and to address the quality of the research conducted and the validity of the sex/gender-specific or sex/gender...

  • Subgroup Analyses: When Should We Believe Them? Ghert, Michelle; Petrisor, Brad // Journal of Bone & Joint Surgery, American Volume;7/18/2012 Supp1, Vol. 94-A, p61 

    The article outlines the correct strategies for implementing subgroup analyses for randomized controlled clinical trials in medicine. It presents guidelines for interpreting the results of subgroup analyses and specific criteria that should be analyzed before making conclusions from subgroup...

  • Gastric Lavage in Acute Organophosphorus Pesticide poisoning (GLAOP) -- a randomised controlled trial of multiple vs. single gastric lavage in unselected acute organophosphorus pesticide poisoning. Yi Li; XueZhong Yu; Zhong Wang; HouLi Wang; XiangHuai Zhao; YuPing Cao; WeiZhan Wang; Eddleston, Michael // BMC Emergency Medicine;2006, Vol. 6, p10 

    Background: Organophosphorus (OP) pesticide poisoning is the most common form of pesticide poisoning in many Asian countries. Guidelines in western countries for management of poisoning indicate that gastric lavage should be performed only if two criteria are met: within one hour of poison...

Share

Read the Article

Courtesy of THE LIBRARY OF VIRGINIA

Sorry, but this item is not currently available from your library.

Try another library?
Sign out of this library

Other Topics